Drug AddictionPhase 2NCT00842036
CRAFT Behavior Therapy: Treatment Entry Component
A Phase 2 study testing Community Reinforcement and Family Training, Treatment Entry Training and 12- step Al/Nar- Anon Facilitation in people with Drug Addiction and Stimulant Dependence, run by Treatment Research Institute at 1 site in United States.
Trial summary
This research compares the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to determine if TEnt alone can produce the primary outcome of CRAFT -- treatment entry of the drug user. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Addiction, Stimulant Dependence, Opiate Dependence
- What is being tested?
- Community Reinforcement and Family Training, Treatment Entry Training and 12- step Al/Nar- Anon Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concerned Significant Other (CSO) and Person of Concern (PC) over 18 years of age
- is a family member (such as a close relative, spouse, intimate partner), roommate or significant other who is concerned about a PC
- reports that the PC has a pattern of drug or alcohol use that meets the criterion for abuse or dependence on stimulants, opiates, or alcohol according to DSM-IV-TR
- reports that the PC is not currently in treatment and has not received treatment during the past 6 weeks (other than detoxification)
- reports having been in the relationship with the identified PC for at least 3 months
- reports contact with the identified PC on at least 12 of the past 30 days with no planned change in the amount of contact in the next 10 months
- provides evidence that the PC has refused to seek treatment when CSO asked
Who cannot join
- does not demonstrate complete understanding of their participation by reading the consent form and passing a consent quiz that tests comprehension of the basic elements of informed consent and requirements of the protocol, or does not agree to participate by signing an informed consent
- declines to: provide valid locator information, allow videotaped sessions, and/or participate in follow-ups
- CSO has a drug abuse problem themselves as determined through clinical assessment and DSM-IV-TR criteria
- is not able to comprehend the content in the self-report materials (written at about 6th grade reading level)
- reports that the PC behaves in a manner consistent with an unremitting psychosis or another psychiatric disorder (e.g., significant developmental delay) that would contraindicate the planned CRAFT intervention
- intends to receive more than 6 hours of individual counseling focusing on the PC's addiction for the 6 months after they are enrolled in the study
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- PC has a recent history of severe domestic violence (e.g., the PC has committed criminal assault during the past 2 years, or has a history of severe violence involving a weapon or resulting in hospitalization
- has an immediate family member, friend, roommate, co-worker, or other person who has already enrolled in the study and his/her participation is not likely to be independent of the initially enrolled CSO's participation
- fails to complete 2 sessions with a family trainer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CRAFT Behavior Therapy Phase 2 Study: Treatment Entry Component
This research compares the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to determine if TEnt alone can produce the primary outcome of CRAFT -- treatment entry of the drug user. We also look at the impact on the well-being of the concerned significant other and the drug use of their loved one.
Read the detailed description
The consequences of drug abuse are not limited to drug users; they also extend to their families and concerned significant others (CSOs). Research shows that CSOs of drug users have increased prevalence of illness, domestic violence, and problems in mood and functioning. Because CSOs are troubled by the negative effects of drug use on the drug user and themselves, they may be a social community that is particularly invested in learning ways to positively influence the drug user.
We compare the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to see if the TEnt is sufficient to produce the primary and most consistent outcome of CRAFT -- treatment entry of the drug user.
- Conditions
- Drug Addiction, Stimulant Dependence, Opiate Dependence, Alcohol Dependence, Substance Abuse
- Being tested
- Community Reinforcement and Family Training, Treatment Entry Training, 12- step Al/Nar- Anon Facilitation
- Keywords
- Family Therapy, Relationship Dysfunction, Family Dysfunction, Family Relations, Stimulant Dependence, Opiate Dependence, Alcohol Dependence, Behavior Therapy, Drug Treatment, Substance Abuse, Drug Addiction
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Reinforcement and Family TrainingBehavioural
Community Reinforcement and Family Training (CRAFT) is an intervention designed for the concerned significant other (CSO) of a drug or alcohol using loved one. The CRAFT intervention consists of approximately 12 sessions lasting 45-60 minutes. The goal of the CRAFT intervention is to train the CSO in new ways to interact with the person of concern (PC). There are four components that the CSO is trained on which include awareness training, community reinforcement training, treatment entry training, and CSO mood enhancement.
Treatment Entry TrainingBehavioural
Treatment Entry Training (TEnT) is a component of the Community Reinforcement and Family Training intervention and it is currently under investigation to determine if it is sufficient to produce the primary and most consistent outcome of CRAFT- treatment entry of the drug user. The intervention will consist of a minimum of 4 sessions and a maximum of 6 sessions that are each 45-60 minutes long. TEnT will include awareness training, safety training, and the Treatment Entry Training component of CRAFT.
12- step Al/Nar- Anon FacilitationBehavioural
The underlying philosophy of the 12- step approach for concerned significant others (CSO) is that the CSO is powerless to control the drinker/drug user and must detach, focusing instead on accepting the situation and on strengthening his or her mental health. Eight content areas are discussed with the CSO over the course of the intervention. There will be a minimum of 8 sessions and a maximum of 12 sessions that are each 45-60 minutes long.
| Study group | Role | What they receive |
|---|---|---|
| ANft | Active comparator | 12- step Al/Nar-Anon Facilitation Receives: Behavioral: 12- step Al/Nar- Anon Facilitation |
| TEnT | Experimental | Treatment Entry Training Receives: Behavioral: Treatment Entry Training |
| CRAFT | Experimental | Community Reinforcement and Family Training Receives: Behavioral: Community Reinforcement and Family Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment entry of the drug user
Measured: This may occur at any point throughout the participants' involvement in the study
Secondary outcomes (2)
Reduction in drug use
Measured: 2 month, 4 month, 6 month, and 9 month assessments
Improvements in mood and functioning
Measured: 2 month, 4 month, 6 month, and 9 month assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Kimberly C Kirby, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842036
- Sponsor's protocol ID
- 0406
- Other IDs
- 5R01DA018696
- Status last verified
- Mar 2023
- First submitted
- 11 Feb 2009
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRAFT Behavior Therapy Phase 2 Study: Treatment Entry Component
- ClinicalTrials.gov ID
- NCT00842036
- Acronym / sponsor ID
- 0406
- Conditions
- Drug Addiction, Stimulant Dependence, Opiate Dependence, Alcohol Dependence, Substance Abuse
- Keywords
- Family Therapy, Relationship Dysfunction, Family Dysfunction, Family Relations, Stimulant Dependence, Opiate Dependence, Alcohol Dependence, Behavior Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research compares the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to determine if TEnt alone can produce the primary outcome of CRAFT -- treatment entry of the drug user. We also look at the impact on the well-being of the concerned significant other and the drug use of their loved one.
Detailed description
The consequences of drug abuse are not limited to drug users; they also extend to their families and concerned significant others (CSOs). Research shows that CSOs of drug users have increased prevalence of illness, domestic violence, and problems in mood and functioning. Because CSOs are troubled by the negative effects of drug use on the drug user and themselves, they may be a social community that is particularly invested in learning ways to positively influence the drug user.
We compare the benefits of the original treatment, Community Reinforcement and Family Training (CRAFT), with the Treatment Entry Training (TEnT) component of CRAFT to see if the TEnt is sufficient to produce the primary and most consistent outcome of CRAFT -- treatment entry of the drug user.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ANft | Active comparator | Behavioral: 12- step Al/Nar- Anon Facilitation12- step Al/Nar-Anon Facilitation |
| TEnT | Experimental | Behavioral: Treatment Entry TrainingTreatment Entry Training |
| CRAFT | Experimental | Behavioral: Community Reinforcement and Family TrainingCommunity Reinforcement and Family Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Concerned Significant Other (CSO) and Person of Concern (PC) over 18 years of age
- is a family member (such as a close relative, spouse, intimate partner), roommate or significant other who is concerned about a PC
- reports that the PC has a pattern of drug or alcohol use that meets the criterion for abuse or dependence on stimulants, opiates, or alcohol according to DSM-IV-TR
- reports that the PC is not currently in treatment and has not received treatment during the past 6 weeks (other than detoxification)
- reports having been in the relationship with the identified PC for at least 3 months
Key exclusion criteria (9 listed)
- does not demonstrate complete understanding of their participation by reading the consent form and passing a consent quiz that tests comprehension of the basic elements of informed consent and requirements of the protocol, or does not agree to participate by signing an informed consent
- declines to: provide valid locator information, allow videotaped sessions, and/or participate in follow-ups
- CSO has a drug abuse problem themselves as determined through clinical assessment and DSM-IV-TR criteria
- is not able to comprehend the content in the self-report materials (written at about 6th grade reading level)
- reports that the PC behaves in a manner consistent with an unremitting psychosis or another psychiatric disorder (e.g., significant developmental delay) that would contraindicate the planned CRAFT intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Reinforcement and Family TrainingCommunity Reinforcement and Family Training (CRAFT) is an intervention designed for the concerned significant other (CSO) of a drug or alcohol using loved one. The CRAFT intervention consists of approximately 12 sessions lasting 45-60 minutes. The goal of the CRAFT intervention is to train the CSO in new ways to interact with the person of concern (PC). There are four components that the CSO is trained on which include awareness training, community reinforcement training, treatment entry training, and CSO mood enhancement. | Behavioural | CRAFT |
| Treatment Entry TrainingTreatment Entry Training (TEnT) is a component of the Community Reinforcement and Family Training intervention and it is currently under investigation to determine if it is sufficient to produce the primary and most consistent outcome of CRAFT- treatment entry of the drug user. The intervention will consist of a minimum of 4 sessions and a maximum of 6 sessions that are each 45-60 minutes long. TEnT will include awareness training, safety training, and the Treatment Entry Training component of CRAFT. | Behavioural | TEnT |
| 12- step Al/Nar- Anon FacilitationThe underlying philosophy of the 12- step approach for concerned significant others (CSO) is that the CSO is powerless to control the drinker/drug user and must detach, focusing instead on accepting the situation and on strengthening his or her mental health. Eight content areas are discussed with the CSO over the course of the intervention. There will be a minimum of 8 sessions and a maximum of 12 sessions that are each 45-60 minutes long. | Behavioural | ANft |
Primary outcome
Treatment entry of the drug user
Time frame: This may occur at any point throughout the participants' involvement in the study
2 secondary outcomes
Reduction in drug use
Time frame: 2 month, 4 month, 6 month, and 9 month assessments
Improvements in mood and functioning
Time frame: 2 month, 4 month, 6 month, and 9 month assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly C Kirby, Ph.D. principal investigator
Treatment Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Community Reinforcement and Family Training, Treatment Entry Training and 12- step Al/Nar- Anon Facilitation in people with Drug Addiction and Stimulant Dependence, run by Treatment Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment entry of the drug user (time frame: This may occur at any point throughout the participants' involvement in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.